Phase 3 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able and willing to sign a consent form and follow the study plan.
• People who are 18 years of age or older.
• People who have been diagnosed through a tissue or cell sample with pancreatic adenocarcinoma (a specific type of pancreatic cancer) that cannot be surgically removed and has either spread locally or to other parts of the body, and who have not yet received treatment for this advanced stage of the disease.
• People whose cancer can be measured or tracked on a CT scan and/or MRI scan.
• People who have a stored tumour tissue sample available for testing.
• People under 70 years old who have a general health rating of 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity but able to carry out light work), or people aged 70 and over who have a rating of 0 (fully active) on that same scale.
• People with a life expectancy of more than 3 months.
• People whose blood cell counts meet minimum levels required by the trial at the screening stage (confirm specific values with trial site).
• People whose liver function blood test results fall within the ranges required by the trial at screening (confirm specific values with trial site).
• People whose kidney function meets the minimum level required by the trial at screening (confirm specific values with trial site).
• People whose blood clotting test results fall within the ranges required by the trial, unless already on blood-thinning medication (confirm with trial site).
• People who do not have a complete deficiency of a specific enzyme called DPYD, as confirmed by genetic testing done at screening (this testing is required).
• Women who could become pregnant and who agree to use highly effective contraception, or to abstain from sex, during the treatment period and for at least 7 months after the last dose of study treatment.
• Women who could become pregnant and who have a negative pregnancy blood test within 7 days of starting the study treatment.
• Men who agree to use highly effective contraception, or to abstain from sex, during the treatment period and for at least 7 months after the last dose of study treatment.
• People who agree not to donate eggs or sperm for the duration of the study and for 7 months after the last dose of study treatment, and who have been made aware that treatment may affect fertility.

Who may not be able to join:

• People whose pancreatic cancer is a type other than adenocarcinoma (such as neuroendocrine, acinar, squamous, adenosquamous, or islet cell tumours).
• People who have already received systemic treatment (such as chemotherapy, targeted therapy, or experimental drugs) for advanced pancreatic adenocarcinoma — though prior treatment given alongside surgery for earlier-stage disease may be acceptable if it was completed more than 9 months ago and the disease has since progressed (confirm with trial site).
• People who have had major surgery or radiation therapy within 4 weeks before joining the trial, or who have not fully recovered from major surgery. (Palliative radiotherapy to bone lesions may be acceptable if completed more than 2 weeks before starting the study treatment — confirm with trial site.)
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who still have unresolved side effects rated grade 2 or higher from previous treatments (other than anaemia or hair loss).
• People who have brain or central nervous system (CNS) spread of their cancer that is causing symptoms, requires treatment such as radiotherapy or surgery, or requires increasing steroid doses within 2 weeks before joining. People with previously treated brain metastases may be considered if they have been neurologically stable for at least 4 weeks (confirm with trial site).
• People with another cancer that is currently active or requires treatment, or who have had another cancer within the past 2 years — except for certain skin cancers, cervical carcinoma in situ, or prostate cancer that has been fully treated.
• People with active, uncontrolled hepatitis B or C infection. People with a past hepatitis B infection that has resolved, or with chronic hepatitis that is controlled by antiviral medication, may be eligible (confirm with trial site).
• People who have had an active infection requiring antibiotics or antifungal medication within 2 weeks before joining.
• People with uncontrolled HIV infection. People with HIV who meet specific criteria around immune cell counts, undetectable viral load, and adherence to HIV treatment may be eligible (confirm with trial site).
• People who are pregnant, breastfeeding, or planning to become pregnant within 7 months of finishing treatment.
• People with serious or uncontrolled heart conditions, such as severe heart failure, unstable chest pain, a heart attack within the past 3 months, or significant heart rhythm problems.
• People with a psychiatric condition that prevents them from understanding the trial information or providing informed consent.
• People with other serious underlying health conditions that, in the treating doctor's judgement, would prevent them from safely participating in the trial.

Important: Always verify eligibility with the trial site directly before applying.